INVSENSOR00027 Clinical Performance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensitivity of INVSENSOR00027's Posture Change Detection
研究概览
简要总结
This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 80 years old
- •Physical status of ASA I or II
- •Subjects must be able to read and communicate in English
- •Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement
- •Has completed Health Assessment Questionnaire and passed health assessment screening
排除标准
- •Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
- •Inability to tolerate sitting still or minimal movement for at least 30 minutes
- •Nursing female volunteers
- •Excluded at the Principal Investigator's discretion
- •Refusal to take the pregnancy test (for female subjects)
- •Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.
- •Refusal to shave hair (neck, chest) off areas where sensors will be applied (male subjects)
研究组 & 干预措施
INVSENSOR00027 Test group
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
干预措施: INVSENSOR00027 (Device)
结局指标
主要结局
Sensitivity of INVSENSOR00027's Posture Change Detection
时间窗: 1-5 hours
For each subject's position detection, INVSENSOR00027 output will be compared against observer's notes at each turn of the subject. Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)
Sensitivity of INVSENSOR00027's Activity Change Detection
时间窗: 1-5 hours
For each subject's activity (e.g., walking and upright) detection, INVSENSOR00027 output will be compared against observer's notes. Correctly detected activity changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's activity change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection).
Sensitivity of INVSENSOR00027's Fall Event Detection
时间窗: 1-5 hours
次要结局
- Respiratory Rate Detection(1-5 hours)